K243192
- 510(k) number
- K243192
- Device name
- iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating
- Applicant
- Nextstep Arthopedix, LLC OH · US
- Product code
- LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Po
- Decision date
- 2026-06-05
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K243192.pdf
Official FDA record: K243192
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.